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The Dutch Presidency of the Council of the European Union today formally informed the Council of Ministers of the agreement that was reached with the European Parliament on 25 May 2016 concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic (IVD) medical devices.

This intervention from the Dutch Presidency followed the endorsement, on 15 June 2016, of the text of the draft Regulations by the Council's Permanent Representatives Committee and the European Parliament's Environment, Public Health and Food Safety (ENVI).

These two Regulations will replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive; bringing about key changes designed to improve safety, transparency and traceability within the EU medical device sector. These include:

Extended definition of the term "medical device" to clearly include medical devices intended to provide prediction and prognosis information in relation to diseases.

Extended scope of the medical devices legislation to include some products (specified) which do not have an intended medical purpose but which present a risk profile similar to medical devices, including: non-prescription contact lenses; facial, dermal or mucous membrane filling substances or articles; liposuction equipment; laser and intense pulsed light equipment for skin treatment; and equipment that applies electrical or magnetic currents for brain stimulation.

A focus on providing users and patients with more information concerning medical devices through the European Databank on Medical Devices (Eudamed).

Improved traceability through assigning a Unique Device Identification (UDI) to each medical device.

Reprocessing (sterilising) and further use of single-use devices may only take place where permitted by national law and only in accordance with the requirements of the Medical Devices Regulation. In addition, the entity or person who reprocesses a single-use medical device would be considered as the legal manufacturer of the reprocessed medical device and would have to assume related obligations.

New classification rules and conformity assessment procedures for IVD medical device. These new rules will have a major impact on the IVD market, where currently around 80% of conformity assessments are through self-assessment, and only 20% by a notified body. The new regulations will mean that these ratios are reversed, a huge change and compliance burden for the industry.

"Many provisions of the new Regulations mark the implementation into law of guidance previously developed under the coordination of the EC in the form of "MEDDEVs" so manufacturers who have been following these as best practice need not be unduly concerned."

Sebastian Lach, Munich product liability partner in the life sciences sector, added:
"Those for whom these regulations may pose a greater challenge are manufacturers affected by the broadened scope of the definition of "medical device". Particularly in the case of products which have a cosmetic rather than medical purpose, we may see many of these disappear from the market as the compliance burden becomes too great or cannot be met. This is part of the resolve behind these regulations – to ensure a safer industry."

Richard Welfare, life sciences regulatory partner in the London commercial group pointed out:
"Yes these regulations will automatically come into force in EU member states without the need for any implementing legislation, and yes they are stricter, but this is generally a good thing. There will be greater harmonisation across Europe and consistency in requirements, all of which are designed to improve the safety and transparency of our sector."

The next step is for the Council to approve the agreement at EU ministers' level. Following a final review, the two draft Regulations are expected to be definitively adopted by the Council and Parliament by the end of 2016. In these circumstances, the Regulation on medical devices would be applicable by end 2019, and the Regulation on in vitro diagnostic medical devices by end 2021.